It was a great mixture of discussion and presentation!
Occurence of Particles in Drug Products
Adverse Effects of Protein Aggregates
Critical Process and Formulation Parameters Parameters
Risk Management & Preventive Actions
Analytical Toolbox: Particulate determination
Limits of Predictive Experiments
Issues and Pitfalls in the Analysis of Aggregates
Impact on Future Demands on Analytical Laboratories
Takeaways & Special Features
• Risk management and preventive actions concerning particulates
• Critical process and formulation parameters
• How to assess aggregates
• About concerns from the authorities and relevant aggregation guidelines
• About factors promoting particle formation
• About real life cases of adverse effects
• Knowledge on utility and limits of predictive experiments
• Overview on statistical analysis of formulation experiments
• Knowledge on removal of aggregates during the manufacturing process
The event showed a good handling of the course's topic. Speakers were well understandable and very open to discussions.
The lecture was very useful!
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